Clinical Trials With a Local Anesthetic Lozenge for the Treatment of Oral Mucosal Pain in Burning Mouth Syndrome, Sjögrens Syndrome and Lichen Planus.
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Chronic Pain
- Sponsor
- Hvidovre University Hospital
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Assessment of oral pain on the Visual Analog Scale
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
Brief Summary
The aim of the project is to do a fase two trial, where the effect of a local anesthetic lozenge will be tested in regard to oral pain, dryness of the mouth, irregularity of taste as well as investigate a potential antiinflammatory effect in patients with burning mouth syndrome, Sjögrens syndrome and lichen planus.
Investigators
Anne Marie Lynge Pedersen
Dentist, PhD
University of Copenhagen
Eligibility Criteria
Inclusion Criteria
- •Diagnosed with burning mouth syndrome, Sjögrens syndrome or lichen planus
- •All fertile women need to use save contraception
- •Age between 18 and 75 years
- •Able to speak, read and understand the danish language
- •Must be informed orally and release a written consent and a signed authorization statement
Exclusion Criteria
- •Pregnant or breastfeeding women
- •Known allergy to bupivacaine or other local anesthetics of the amide type
- •Active infection which requires antibiotic treatment
- •Patients in immune suppressive treatment
Arms & Interventions
Placebo lozenge
The patients will be randomized to start two weeks treatment with either a bupivacaine lozenge or a placebo lozenge (taken three times a day). The two weeks treatment is followed by a week without treatment. Afterwards they start another two weeks treatment with the opposite type of lozenge from the first treatment period.
Intervention: Placebo
Bupivacaine lozenge
The patient will be randomized to start two weeks treatment with either a bupivacaine lozenge or a placebo lozenge (taken three times a day). The two weeks treatment is followed by a week without treatment. Afterwards the patient starts another two weeks treatment with the opposite type of lozenge from the first treatment period.
Intervention: Bupivacaine
Outcomes
Primary Outcomes
Assessment of oral pain on the Visual Analog Scale
Time Frame: The patients assess their oral pain when they attend the four examinations and they fill in a diary for a total of four weeks.
Assessment of oral pain in patients with burning mouth syndrome, Sjögrens syndrome or lichen planus after treatment with a bupivacaine lozenge or a placebo lozenge. The patient assess their oral pain on the visual analog scale when they attend the four examinations. The patients also fill in a diary for a total of four weeks where they are in treatment where they assess VAS for pain, dryness of the mouth and irregularity of taste
Secondary Outcomes
- Measure the inflammation markers in blood, saliva and tissue(Blood- and saliva samples are taken the four times the patient attend the examinations. They are taken over a periode of five weeks. Tissue samples are taken before the first treatment period starts and when the final treatment period is finished.)